Heathly VolunteersNCT07618000
PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition
A study testing PI-YSP-0111 formulation (High-dose) and PI-YSP-0111 formulation (Low-dose) in people with Heathly Volunteers, run by Taipei Medical University at 2 sites in Taiwan.
Trial summary
The expected outcome of this study is that continuous 8-week supplementation with the PI-YSP-0111 prebiotic formulation will exert beneficial effects on gut microbiota modulation and liver health. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Heathly Volunteers
- What is being tested?
- PI-YSP-0111 formulation (High-dose) and PI-YSP-0111 formulation (Low-dose)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 2 sitesTaiwan
- Study dates
- 8 Apr 2026to 7 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males or females aged 18 to 65 years.
- BMI between 23.0 and 40.0 kg/m².
- Waist circumference: ≥ 90 cm for males and ≥ 80 cm for females.
- Participants are willing to maintain their usual dietary habits, daily routines, and physical activity levels during the study period, and have no plans to relocate.
- Participants have fully understood the study procedures and have signed the informed consent form.
Who cannot join
- Presence of gastrointestinal diseases, such as inflammatory bowel disease, irritable bowel syndrome, gastroesophageal reflux disease, Crohn's disease, or a history of bariatric surgery.
- Recent history of acute gastroenteritis, constipation or diarrhea; psychiatric disorders (e.g., depression or schizophrenia); cardiovascular diseases (e.g., hypertension); known allergy or hypersensitivity to the investigational product; extreme dietary habits; significant body weight change (>4.5 kg) within the past three months; recent use of antibiotics or antifungal agents; or use of medications affecting gastrointestinal function (such as probiotics, laxatives, or nonsteroidal anti-inflammatory drugs [NSAIDs]).
- Exposure to unapproved medications, alcohol abuse, or substance abuse.
- Female-specific conditions, including significant gastrointestinal symptoms during menstruation, irregular menstrual cycles, pregnancy, planned pregnancy, or breastfeeding (participants who become pregnant during the study period will also be excluded).
- Short-term use of corticosteroids, nonsteroidal anti-inflammatory drugs, immunosuppressive agents, interferons, or immunomodulatory agents within the past one month.
- Use of any weight-loss medications (including oral agents, injections, or traditional Chinese medicine) within the past three months.
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- Participation in any other interventional clinical study within the past one month.
- History of cancer or current malignancy within the past two years, except for non-melanoma skin cancer.
- Occurrence of major trauma or any surgical procedures within the past one month.
- History of diabetic ketoacidosis.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Taipei Medical University
Taipei, Taiwan, 110
Ming Ta Yang, Professor, +886-2-27361661 ext. 2275, yangrugby@tmu.edu.tw
- Recruiting
Taipei Municipal WanFang Hospital(Managed by Taipei Medical University)
Taipei, Taiwan, 116
Ming Ta Yang, Professor, +886-2-27361661 ext. 2275, yangrugby@tmu.edu.tw
About this study
Official title: Evaluation of the Effects of the PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition
The expected outcome of this study is that continuous 8-week supplementation with the PI-YSP-0111 prebiotic formulation will exert beneficial effects on gut microbiota modulation and liver health.
Read the detailed description
All participants will undergo blood, urine, and fecal sample collection at baseline and after 8 weeks of supplementation. Body composition measurements and questionnaire assessments will be conducted at baseline, after 4 weeks, and after 8 weeks of supplementation. The collected data will be analyzed using a two-way mixed-design analysis of variance (ANOVA) to compare both between-group and within-group differences.
- Conditions
- Heathly Volunteers
- Being tested
- PI-YSP-0111 formulation (High-dose), PI-YSP-0111 formulation (Low-dose), Placebo group(High-dose), Placebo group(Low-dose)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PI-YSP-0111 formulation (High-dose)Dietary supplement
6 per day(Lactobacillus rhamnosus MB17, Lactobacillus plantarum MB-10, Grape Seed extract, Oligo, Wofberry Extract Powder, Maltose powder, Aerosil, Magnesium Stearate)
PI-YSP-0111 formulation (Low-dose)Dietary supplement
4 per day(Lactobacillus rhamnosus MB17, Lactobacillus plantarum MB-10, Grape Seed extract, Oligo, Wofberry Extract Powder, Maltose powder, Aerosil, Magnesium Stearate)
Placebo group(High-dose)Dietary supplement
6 per day(Maltose powder, Aerosil, Magnesium Stearate)
Placebo group(Low-dose)Dietary supplement
4 per day(Maltose powder, Aerosil, Magnesium Stearate)
| Study group | Role | What they receive |
|---|---|---|
| high-dose intervention group | Experimental | Not described Receives: Dietary Supplement: PI-YSP-0111 formulation (High-dose) |
| low-dose intervention group | Experimental | Not described Receives: Dietary Supplement: PI-YSP-0111 formulation (Low-dose) |
| high-dose placebo group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo group(High-dose) |
| low-dose placebo group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo group(Low-dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Ketone Bodies
Measured: week0 and week8
Albumin
Measured: Week0 and week8
Aspartate Aminotransferase (AST)
Measured: week0 and week8
Alanine Aminotransferase (ALT)
Measured: week0 and week8
Gamma-Glutamyl Transferase (GGT)
Measured: week0 and week8
Blood Creatinine
Measured: week0 and week8
Blood Urea Nitrogen (BUN)
Measured: week0 and week8
Uric Acid
Measured: week0 and week8
Sodium (Na⁺)
Measured: week0 and week8
Potassium (K⁺)
Measured: week0 and week8
Free Fatty Acids (FFA)
Measured: week0 and week8
Thyroid Stimulating Hormone (TSH)
Measured: week0 and week8
white blood cell (WBC) count/automated differential
Measured: week0 and week8
red blood cell (RBC) count
Measured: week0 and week8
hemoglobin
Measured: week0 and week8
hematocrit
Measured: week0 and week8
platelet count
Measured: week0 and week8
mean corpuscular volume (M.C.V)
Measured: week0 and week8
mean corpuscular hemoglobin concentration (M.C.H.C)
Measured: week0 and week8
total cholesterol (TC)
Measured: week0 and week8
high-density lipoprotein cholesterol (HDL-C)non-HDL-C
Measured: week0 and week8
low-density lipoprotein cholesterol (LDL-C)
Measured: week0 and week8
triglycerides (TG)
Measured: week0 and week8
glucose AC
Measured: week0 and week8
Height
Measured: week0 , week4 and week8
Weight
Measured: week0 , week4 and week8
Body Mass Index (BMI)
Measured: week0 , week4 and week8
Body Composition (muscle mass, fat mass, visceral fat level)
Measured: week0 , week4 and week8
Hip Circumference
Measured: week0 , week4 and week8
Waist-to-Hip Ratio (WHR)
Measured: week0 , week4 and week8
Fecal Sample(Akkermansia muciniphila, qPCR (quantitative polymerase chain reaction))
Measured: week0, week8
Next-Generation Sequencing (NGS)
Measured: week0 and week8
Urinalysis
Measured: week0 and week8
Dietary Record
Measured: week0 , week4 and week8
Bowel Movement Record
Measured: week0 , week4 and week8
Gastrointestinal Questionnaire
Measured: Week0 , week4 and week8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start8 Apr 2026
- Primary completion7 Apr 2027 (estimated)
- Study completion7 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heathly VolunteersStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of four groups: a high-dose intervention group, a low-dose intervention group, a high-dose placebo group, and a low-dose placebo group (35 participants per group).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Yung Shin Pharm. Ind. Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618000
- Sponsor's protocol ID
- N202603016
- Status last verified
- Apr 2026
- First submitted
- 26 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of the PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition
- ClinicalTrials.gov ID
- NCT07618000
- Acronym / sponsor ID
- N202603016
- Conditions
- Heathly Volunteers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Yung Shin Pharm. Ind. Co., Ltd.
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 7 Apr 2027 (estimated)
- Study completion
- 7 Apr 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The expected outcome of this study is that continuous 8-week supplementation with the PI-YSP-0111 prebiotic formulation will exert beneficial effects on gut microbiota modulation and liver health.
Detailed description
All participants will undergo blood, urine, and fecal sample collection at baseline and after 8 weeks of supplementation. Body composition measurements and questionnaire assessments will be conducted at baseline, after 4 weeks, and after 8 weeks of supplementation. The collected data will be analyzed using a two-way mixed-design analysis of variance (ANOVA) to compare both between-group and within-group differences.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned to one of four groups: a high-dose intervention group, a low-dose intervention group, a high-dose placebo group, and a low-dose placebo group (35 participants per group).
| Arm | Type | Receives |
|---|---|---|
| high-dose intervention group | Experimental | Dietary Supplement: PI-YSP-0111 formulation (High-dose) |
| low-dose intervention group | Experimental | Dietary Supplement: PI-YSP-0111 formulation (Low-dose) |
| high-dose placebo group | Placebo comparator | Dietary Supplement: Placebo group(High-dose) |
| low-dose placebo group | Placebo comparator | Dietary Supplement: Placebo group(Low-dose) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy males or females aged 18 to 65 years.
- BMI between 23.0 and 40.0 kg/m².
- Waist circumference: ≥ 90 cm for males and ≥ 80 cm for females.
- Participants are willing to maintain their usual dietary habits, daily routines, and physical activity levels during the study period, and have no plans to relocate.
- Participants have fully understood the study procedures and have signed the informed consent form.
Key exclusion criteria (10 listed)
- Presence of gastrointestinal diseases, such as inflammatory bowel disease, irritable bowel syndrome, gastroesophageal reflux disease, Crohn's disease, or a history of bariatric surgery.
- Recent history of acute gastroenteritis, constipation or diarrhea; psychiatric disorders (e.g., depression or schizophrenia); cardiovascular diseases (e.g., hypertension); known allergy or hypersensitivity to the investigational product; extreme dietary habits; significant body weight change (>4.5 kg) within the past three months; recent use of antibiotics or antifungal agents; or use of medications affecting gastrointestinal function (such as probiotics, laxatives, or nonsteroidal anti-inflammatory drugs [NSAIDs]).
- Exposure to unapproved medications, alcohol abuse, or substance abuse.
- Female-specific conditions, including significant gastrointestinal symptoms during menstruation, irregular menstrual cycles, pregnancy, planned pregnancy, or breastfeeding (participants who become pregnant during the study period will also be excluded).
- Short-term use of corticosteroids, nonsteroidal anti-inflammatory drugs, immunosuppressive agents, interferons, or immunomodulatory agents within the past one month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PI-YSP-0111 formulation (High-dose)6 per day(Lactobacillus rhamnosus MB17, Lactobacillus plantarum MB-10, Grape Seed extract, Oligo, Wofberry Extract Powder, Maltose powder, Aerosil, Magnesium Stearate) | Dietary supplement | high-dose intervention group |
| PI-YSP-0111 formulation (Low-dose)4 per day(Lactobacillus rhamnosus MB17, Lactobacillus plantarum MB-10, Grape Seed extract, Oligo, Wofberry Extract Powder, Maltose powder, Aerosil, Magnesium Stearate) | Dietary supplement | low-dose intervention group |
| Placebo group(High-dose)6 per day(Maltose powder, Aerosil, Magnesium Stearate) | Dietary supplement | high-dose placebo group |
| Placebo group(Low-dose)4 per day(Maltose powder, Aerosil, Magnesium Stearate) | Dietary supplement | low-dose placebo group |
Primary outcome
Serum Ketone Bodies
Time frame: week0 and week8
Albumin
Time frame: Week0 and week8
Aspartate Aminotransferase (AST)
Time frame: week0 and week8
Alanine Aminotransferase (ALT)
Time frame: week0 and week8
Gamma-Glutamyl Transferase (GGT)
Time frame: week0 and week8
Blood Creatinine
Time frame: week0 and week8
Blood Urea Nitrogen (BUN)
Time frame: week0 and week8
Uric Acid
Time frame: week0 and week8
Sodium (Na⁺)
Time frame: week0 and week8
Potassium (K⁺)
Time frame: week0 and week8
Free Fatty Acids (FFA)
Time frame: week0 and week8
Thyroid Stimulating Hormone (TSH)
Time frame: week0 and week8
white blood cell (WBC) count/automated differential
Time frame: week0 and week8
red blood cell (RBC) count
Time frame: week0 and week8
hemoglobin
Time frame: week0 and week8
hematocrit
Time frame: week0 and week8
platelet count
Time frame: week0 and week8
mean corpuscular volume (M.C.V)
Time frame: week0 and week8
mean corpuscular hemoglobin concentration (M.C.H.C)
Time frame: week0 and week8
total cholesterol (TC)
Time frame: week0 and week8
high-density lipoprotein cholesterol (HDL-C)non-HDL-C
Time frame: week0 and week8
low-density lipoprotein cholesterol (LDL-C)
Time frame: week0 and week8
triglycerides (TG)
Time frame: week0 and week8
glucose AC
Time frame: week0 and week8
Height
Time frame: week0 , week4 and week8
Weight
Time frame: week0 , week4 and week8
Body Mass Index (BMI)
Time frame: week0 , week4 and week8
Body Composition (muscle mass, fat mass, visceral fat level)
Time frame: week0 , week4 and week8
Hip Circumference
Time frame: week0 , week4 and week8
Waist-to-Hip Ratio (WHR)
Time frame: week0 , week4 and week8
Fecal Sample(Akkermansia muciniphila, qPCR (quantitative polymerase chain reaction))
Time frame: week0, week8
Next-Generation Sequencing (NGS)
Time frame: week0 and week8
Urinalysis
Time frame: week0 and week8
Dietary Record
Time frame: week0 , week4 and week8
Bowel Movement Record
Time frame: week0 , week4 and week8
Gastrointestinal Questionnaire
Time frame: Week0 , week4 and week8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PI-YSP-0111 formulation (High-dose) and PI-YSP-0111 formulation (Low-dose) in people with Heathly Volunteers, run by Taipei Medical University at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Ta Yang, Professor (+886-2-27361661 ext. 2275, yangrugby@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Ketone Bodies (time frame: week0 and week8). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.